The MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device includes breakthrough technology that is designed to provide information related to myocardial energy that may be used by physicians as part of an overall risk assessment to assist in determining whether a patient should receive further testing, evaluation and/or treatment. HeartSciences’ breakthrough innovation in electrocardiography adds new features that enhance patient screening for the detection of heart disease.

The MyoVista wavECG Device benefits from more than ten years of research and development by HeartSciences to improve the ability of an ECG to detect structural and ischemic heart disease. The MyoVista wavECG Device has a sensitivity of 74.3% and a specificity of 72.9%* for the detection of myocardial relaxation abnormalities associated with LVDD.

GJ Burch of Oxford devises an arithmetical correction for the observed (sluggish) fluctuations of the electrometer. This allows the true waveform to be seen after tedious calculations.

1895

Einthoven, completes the first accurate recording of the electrocardiogram as a clinical tool, and distinguishes five deflections which he names P, Q, R, S and T.

1893

Willem Einthoven introduces the term ‘electrocardiogram’ at a meeting of the Dutch Medical Association. (Later he claims that Waller was first to use the term).

1902

Einthoven publishes the first electrocardiogram recorded on a string galvanometer

1903

Einthoven discusses commercial production of a string galvanometer with Max Edelmann of Munich and Horace Darwin of Cambridge Scientific Instruments Company of London.

1905

Einthoven starts transmitting electrocardiograms from the hospital to his laboratory 1.5 km away via telephone cables. On March 22nd the first ‘telecardiogram’ is recorded.

1906

Einthoven publishes the first organized presentation of normal and abnormal electrocardiograms recorded with a string galvanometer.

1908

Edward Schafer of the University of Edinburgh is the first to buy a string galvanometer for clinical use.

1910

Walter James, Columbia University and Horatio Williams, Cornell University Medical College, New York publish the first American review of electrocardiography.

1924

Einthoven wins the Nobel prize for inventing the electrocardiograph.

1931

Charles Wolferth and Francis Wood describe the use of exercise to provoke attacks of angina pectoris.

1932

Charles Wolferth and Francis Wood describe the clinical use of chest leads.

1932

Goldhammer and Scherf propose the use of the electrocardiogram after moderate exercise as an aid to the diagnosis of coronary insufficiency.

1934

By joining the wires from the right arm, left arm and left foot with 5000 Ohm resistors Frank Wilson defines an ‘indifferent electrode’ later called the ‘Wilson Central Terminal’. The combined lead acts as an earth and is attached to the negative terminal of the ECG. An electrode attached to the positive terminal then becomes ‘unipolar’ and can be placed anywhere on the body. Wilson defines the unipolar limb leads VR, VL and VF where ‘V’ stands for voltage.

1938

American Heart Association and the Cardiac Society of Great Britain define the standard positions, and wiring, of the chest leads V1 – V6. The ‘V’ stands for voltage.

1942

Emanuel Goldberger increases the voltage of Wilson’s unipolar leads by 50% and creates the augmented limb leads aVR, aVL and aVF. When added to Einthoven’s three limb leads and the six chest leads we arrive at the 12-lead electrocardiogram that is used today.

1948

Rune Elmqvist, Swedish engineer introduces the first ink jet printer for the transcription of analog physiological signals. He demonstrates its use in the recording of ECGs at the First International Congress of Cardiology in Paris in 1950.

1962

The Holter monitor was released for commercial production – developed at the Holter Research Laboratory in Helena Montana by experimental physicists Norman J. Holter and Bill Glasscock.

1963

Robert Bruce and colleagues describe their multistage treadmill exercise test later known as the Bruce Protocol.

1968

Journal of Electrocardiography, the Official Journal of the International Society for Computerized Electrocardiology and the International Society of Electrocardiology, is founded by Zao and Lepeschkin.

1978

Hewlett Packard introduces its first commercial 12 lead ECG with interpretive analysis

1993

Robert Zalenski, Professor of Emergency Medicine, Wayne State University Detroit, and colleagues publish an influential article on the clinical use of the 15-lead ECG which routinely uses V4R, V8 and V9 in the diagnosis of acute coronary syndromes. These additional leads increased the sensitivity of the electrocardiogram in detecting myocardial infarction.

2008

HeartSciences, Incorporates and begins research and development of the first application-use of continuous wavelet transform signal processing for the electrocardiograph with the goal to significantly improve the sensitivity and specificity of ECG performance in the early detection of heart disease

Current ECGs are highly effective at detecting arrhythmias but have limited sensitivity in detecting structural or ischemic heart disease.

Conventional ECG Devices vs. the MyoVista wavECG Device:

Current ECGs have limited sensitivity in identifying structural and ischemic heart disease. The MyoVista wavECG Device assists physicians in detecting relaxation abnormalities associated with LVDD that may be caused by structural and or ischemic heart disease not identified using current low-cost testing methods. This may assist physicians in determining if a patient should receive further testing, evaluation and/or treatment.

MyoVista wavECG Device is a significant advancement in low-cost ECG testing to provide physicians with new information to assist in risk-assessment for heart disease such as:

Advanced diagnostics may also include risks: (i.e. radiation, infection, embolism)

Addressing the need for modern innovative low-cost cardiac testing tools

Statistics show over 50% of patients find out they have heart disease through an adverse event*. The MyoVista wavECG Device assists in identifying patients with heart disease early. This allows patients to be treated earlier, improving quality of care and patient outcomes while lowering care-pathway costs.

Includes conventional 12-lead ECG information and Glasgow Interpretive Analysis Report in the same test

Reimbursable- use of conventional resting 12-lead ECG coding

Quick: 20/30/60 second test with immediate results

Eliminates need for conventional thermal recording chart paper

MyoVista Energy Waveform

The MyoVista Energy Waveform graphically displays the energy distribution pattern of the heart’s electrical activity during each phase of the cardiac cycle. It is visually aligned with the conventional ECG trace and provided on a lead by lead basis.

The MyoVista Energy Waveform is displayed as a color scale (scalogram) and represents the ECG signal after transformation using continuous wavelet transform mathematics. The scalogram provides a non-linear mapping of energy and depicts the level of energy detected from the heart at each point in time and frequency. Blue represents low energy, red represents high energy, and intermediate energy levels are shown according to the red, blue and green (RGB).

This visual representation is provided to give context for the remainder of the wavelet measures and statements provided by the MyoVista Device.

The MyoVista Energy Waveform is the ECG signal display after wavelet signal processing

Horizontal axis (x-axis) is time

Vertical axis (y-axis) is frequency

Frequencies range from 3 Hz (bottom) to 200 Hz (top)

Color scaling provides additional (non-linear) mapping of energy

Color represents a level of energy at each point in time and frequency

Blue represents low energy, red represents high energy

MyoVista Ventricular Indices

The MyoVista Energy Waveform graphically displays the energy distribution pattern of the heart’s electrical activity during each phase of the cardiac cycle. It is visually aligned with the conventional ECG trace and provided on a lead by lead basis.

The MyoVista Energy Waveform is displayed as a color scale (scalogram) and represents the ECG signal after transformation using continuous wavelet transform mathematics. The scalogram provides a non-linear mapping of energy and depicts the level of energy detected from the heart at each point in time and frequency. Blue represents low energy, red represents high energy, and intermediate energy levels are shown according to the red, blue and green (RGB).

This visual representation is provided to give context for the remainder of the wavelet measures and statements provided by the MyoVista Device.

MyoVista Wavelet Analysis, Algorithms and Statements

The MyoVista Wavelet Analysis, Algorithms and Statements provide the results of the Wavelet Analysis (with inputs from the MyoVista Ventricular Indices, as well as other conventional measures such as T-Axis, sex, and age) and provides statements which can be used to assist physicians in the assessment of patients having relaxation abnormalities associated with LV diastolic dysfunction that may require further clinical testing, evaluation and/or treatment.

Conventional ECG Trace with Interpretive Anaysis

The MyoVista wavECG Device provides conventional ECG trace information as well as the University of Glasgow 12-lead ECG Interpretive Analysis Algorithm that has more than 35 years of history and is considered one of the leading ECG interpretive algorithms in the world.

Analysis

Advanced signal processing using Continuous Wavelet Transform (CWT) mathematics is designed to enable the MyoVista wavECG Device to graphically displays the energy distribution pattern of the heart’s electrical activity during each phase of the cardiac cycle. It is visually aligned with the conventional ECG trace and provided on a lead by lead basis.

Advanced cardiac imaging modalities such as CT, MRI, ECHO, and PET scans all use and are dependent on advanced digital signal processing.

The MyoVista wavECG Device assists in the early identification of heart disease which may be related to electrical, ischemic or structural conditions.

Carol Krieger

Vice President of Clinical and Regulatory

Carol Krieger is an experienced RA/QA/Clinical professional with medical device experience and a demonstrated success as an agent of change in building and rebuilding compliant clinical an regulatory systems. Carol has over 30 years of clinical and regulatory experience and has led and trained clinical staff while holding strategic management positions in both large and small companies. She is a true proponent and implementer of the global cross-functional team process and is adept at working simultaneously at multiple levels, as both an individual and a strategic contributor. Carol demonstrates a steady and persistent presence through difficult regulatory challenges while maintaining a focus on driving company objectives and goals.

Carol most recently served as the Director of Clinical Quality Assurance and Compliance at Becton Dickenson and Company. Prior she served as Vice President of Clinical Operations for BioConnect Systems.

Carol holds a Master of Science in Jurisprudence Degree from Seton Hall University School of Law, a Master of Business Administration Degree from Montclair State University, as well as a Bachelor of Science Degree in Medical Technology from Rutgers University.

Prof. Peter Macfarlane

Clinical Advisor

Professor Peter W. Macfarlane, DSc eFESC FRSE, is an expert in the field of electrocardiology and has over 40 years’ experience in the development of computer-based systems for the interpretation of ECGs. He has authored over 300 publications and peer-reviewed papers, as well as numerous books on the subject. Professor Macfarlane is recognized as a pioneer in the use of computers in hospital-based ECG interpretation. The work of his team has been adopted commercially, and the University of Glasgow ECG interpretation analysis developed in his laboratory is currently used worldwide. The Glasgow analysis is incorporated in the MyoVista® wavECG™ Device where it complements HeartSciences by providing computerized analysis of the conventional ECG waveform. At present, he is Emeritus Professor and Honorary Senior Research Fellow of the University of Glasgow. In 2014, Professor Macfarlane was awarded a CBE for services to British healthcare.

Peter is the current President of the International Society of Computerized Electrocardiology (ISCE). He also serves as Treasurer of the International Society of Electrocardiology (ISE), having been President in the past. His major interest throughout his career has been the application of computer techniques to ECG interpretation.

Dr. James Terry

Clinical Advisor

Dr. James Terry, past President of the Tarrant County Academy of Family Physicians (TCAFP) has been practicing medicine since 1987. He earned his M.D. from UT Southwestern in 1984, and has held numerous leadership roles throughout his career. Dr. Terry has served as the former President of Health Partners Medical Group, and Chief Quality Officer for Texas Health Physicians’ Group (THPG). Currently a member of Texas Academy of Family Physicians (TAFP), he also serves as diplomat of American Academy of Family Physicians (AAFP), in addition to caring for his patients at Mid-Cities Family Care in Bedford, Texas.

HeartSciences

Drew Diaz

Cofounder

Drew is a cofounder of HTL and was its CEO during the development phase of the MyoVista. He has over twenty six years’ experience in the domestic and international medical device business. Drew is also the cofounder of Foundation I-4 which is dedicated to the advancement of cardiac imaging technology. He was Senior Vice President of Global Sales for Criticare Systems Inc., a US based manufacturer of anesthesia, cardiac and patient monitoring equipment. Drew also held positions with IBM, Pfizer, and DeRoyal Industries, and was the Managing Director and President of Medical Logistics GMbH, a medical device company in Germany. Drew has worked and lived in various countries and has experience in opening new markets and driving revenue via distribution networks, which will be an important part of the growth of HTL. Drew currently sits on the Board of Directors for Bone Solutions Inc., an orthopedic biologics technology company based in Dallas Texas.

HeartSciences

Dr. Partho Sengupta

Clinical Advisor

Partho Sengupta, MD is the Chief of Cardiology of West Virginia University, Heart and Vascular Institute as well as the, director of Cardiovascular Imaging, the chair of Cardiovascular Innovation, and a professor of Medicine. Prior to joining WVU Medicine, Dr. Sengupta was the director of interventional echocardiography, cardiac ultrasound research, and core lab at Mount Sinai’s Zena and Michael A. Weiner Cardiovascular Institute and the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health.

Dr. Sengupta received his medical degree from Government Medical College in India, where he also completed a residency. He then completed a cardiology fellowship from All India Institute of Medical Sciences and a cardiology fellowship at both Mayo Clinic in Minnesota and Arizona.

Dr. Sengupta is the associate editor of the Journal of American College of Cardiology: Cardiovascular Imaging, section editor for the Journal of American College of Cardiology, on the editorial board of eight cardiology journals, and has over 200 publications and text book chapters. He is the current chair of Innovation Task Force at the American Society of Echocardiography. He has been a TedMed speaker and has been recognized as a Top 25 professor of ultrasound medicine. Dr. Sengupta is board certified in internal medicine, cardiovascular medicine, and echocardiography.

HeartSciences

Joe Schwoebel

Vice President Clinical and Regulatory Affairs

Joe has over 30 years’ experience in medical device clinical studies, regulatory affairs and quality assurance with several companies, including firms ranging from large multinational to startups. The majority of his experience is with cardiovascular products, comprising an ideal fit with the product focus of Heart Test Laboratories. A brief summary of his company experience includes Pacesetter Systems, Inc (acquired by St. Jude Medical), Biotronik GmbH, CardiacAssist, Health Hero Network (acquired by Bosch Healthcare), Pharmaceutical Product Development (PPD) and Neuros Medical, Inc.
He has organized and completed 12 IDEs leading to market release of medical devices in the United States, European Union, and other major markets. During his career, Joe has secured FDA clearance of 75 510(k)s, 6 Original PMAs, 100+ PMA Supplements, as well as CE Marks (European Union), Canadian MDLs (Canada), and product approvals throughout Asia, Australia, Middle East, Eastern Europe and Russia. Joe is an active member of RAPS, SEMDA, and has participated on various AdvaMed committees in Washington, DC.

HeartSciences

Aaron Peterson

Vice President Research and Development

Aaron Peterson is a highly respected veteran of designing and creating innovative products in the Medical Device industry. Aaron has over 25 years of Engineering and Product Development experience and has successfully productized multiple innovative technologies in the areas of Cardiac Rhythm Management, Neurostimulation and electrocardiography-based devices. On multiple occasions, Aaron has demonstrated the ability evolve raw ideas into commercially successful products such as Cardiac Resynchronization Therapy ($3.1B market), Remote Patient Monitoring ($500M market), and Spinal Column Stimulation ($1.7B market).

Aaron believes in not only building great products, but great organizational capability and culture, which has set him apart as a great leader. He has received numerous awards throughout his career for his technical contributions as well as for Quality, Process Improvements and Cost Reduction initiatives. Aaron has recently been featured in several online articles where he continues to emerge as a highly respected Medical Device Entrepreneur and thought leader.

Aaron holds a master’s Degree in Computer Science from Utah State University as well as several professional certifications, including a Project Management Professional (PMP) certification with the Project Management Institute (PMI).

HeartSciences

Tess Jackovich

Vice President, Market Development

Tess has over 30 years’ experience in business development, training and sales in the medical device industry. She joined HeartSciences in 2008 as a member of its founding management team. Prior to that, she was Clinical Specialist and Regional Sales Manager for Criticare, where she oversaw sales and clinical training for the company’s state-of-the-art, non-invasive blood pressure and critical care monitors. Tess also has more than 15 successful years growing revenue as a front-line sales representative for critical care products including cardiology, anesthesia, respiratory, labor and delivery, surgery, ICU, emergency and telemetry.

HeartSciences

Brian Allen

With 20 plus years of medical device experience Brian brings an accomplished track record of multiple first-to-market disruptive innovations, developing go-to-market strategies, and building successful commercialization teams to earn mainstream market adoption. Brian served as Vice President of Sales and Commercial Marketing for OrthoSensor Inc., where he led global market expansion through distribution partnerships. Brian also led the company’s domestic commercial launch of VERASENSE; the orthopedic industry’s first Sensor-assisted-surgery technology for total knee replacements. Prior to OrthoSensor, Brian served as Director of Sales and Marketing for MAKO Surgical and was responsible for the commercial launch of the orthopedic industry’s first Robotic-assisted Surgery System. MAKO Surgical Corp was acquired by Stryker Inc. for $1.65B (2013). Earlier career positions include progressive sales roles at Medtronic, Zimmer Inc., and Burrows Inc. (now Owens and Minor, Inc.).

HeartSciences

Paul Klotz

Senior Vice President Operations

Paul has over 25 years’ experience as a senior operations executive enabling both public and privately held companies to rapidly maximize top-line growth and profitability by building scalable, efficient organizations that balance the pace of change while effectively managing risk. Paul has successfully built and operated complex, high-growth businesses across multiple industries and geographies, including, technology distribution, consumer products design, manufacturing and distribution, technology service logistics, and technology infrastructure consulting and managed services. Paul also serves on the board of directors for The Children’s Advocacy Center for Denton County.

HeartSciences

John Q. Adams Sr.

Board Member

Mr. Adams is a serial entrepreneur and has enjoyed a long career in the healthcare industry. In 1969, he founded Baylor Laboratories, Inc. which he sold to the Norwich Eaton Pharmaceutical division of Morton Norwich, Inc. in 1980. He then founded Allerderm, Inc. which was purchased by Vibrac, Inc. in 1985. In 1985, Mr. Adams founded Adams Laboratories, Inc. and sold it in 1992 to Medeva PLC, a listed company in the United Kingdom following which he served on Medeva’s Board of Directors until 1997 and as an Executive Director, holding various offices, until 1995. He later repurchased certain assets from Medeva to reform Adams Laboratories, Inc. in 1999 where he served as CEO until 2003. Adams Laboratories changed its name to Adams Respiratory Therapeutics, Inc. where Mr. Adams served as Chairman until October 2005 having led it through a highly successful IPO. Adams Respiratory developed prescription and non-prescription pharmaceuticals for the treatment of respiratory disorders and diseases, including Mucinex™, and was subsequently acquired by Reckitt Benckiser Group in late 2007.
Mr. Adams continues to be an active investor in healthcare companies and retains memberships and board positions in several professional and philanthropic organizations, including the American College of Allergy and the Vanderbilt University Voice Center. In July 2007, he was elected to the Board of Trustees for Heidelberg College in Tiffin, Ohio, and in April 2009 he was inducted into the Hall of Excellence of the Ohio Foundation of Independent Colleges. He is also an Honorary Fellow of the American Academy of Otolaryngology-Head and Neck Surgery. Mr. Adams holds a degree in Biology from Heidelberg College.

HeartSciences

John D. Owen

Board Member

Mr. Owen is a full time private investor with a particular interest in the medical device sector and is an existing investor in Heart Test Labs. He has extensive experience in high growth start-ups and in securing investment from both private and public capital sources including IPOs. He will be a welcome addition to the Board as we position HTL for rapid growth and major institutional involvement in 2017. John will Chair the Audit Committee of HTL’s Board.
Prior to John’s focus on private investment, he was most notably a co-founder of JetBlue Airways and was its CFO from inception in 1999 through 2006. During his tenure JetBlue went from a start-up to a successful NASDAQ-listed company with over $2 billion in revenue. John managed multiple public and private funding rounds as well as its IPO. Subsequently he acted as CFO and adviser to Volotea Airlines during its start-up which included raising €65 million in equity financing prior to its commencement of flight operations in 2012. We are delighted to have John join as a Director. He holds a BA in Economics from SMU, summa cum laude and Phi Beta Kappa, and an MBA in Finance from the Wharton School where he was a Mayer Fellow.

HeartSciences

Brian Szymczak

Board Member

Brian Szymczak is the lead attorney for Apollo Endosurgery, Inc. (Nasdaq: APEN) in Austin, Texas where he serves as Vice President, Legal. In this role Mr. Szymczak manages legal disputes and litigation matters and provides general legal counsel to the company’s leadership, sales, operations, R&D and human resources groups. Prior to working at Apollo, Mr. Szymczak served as Associate General Counsel and Director of Legal Affairs for a large surgical device manufacturer and previously worked as an associate at the law firm of Baker Botts, LLP where he counseled clients on patent and other intellectual property matters in a variety of technological fields. Mr. Szymczak is a 1999 graduate of Duke University, School of Law and holds a Bachelor of Science in Mechanical Engineering from Texas A&M University.

HeartSciences

Dr. Richard Gray

Board Member and Clinical Advisor

Dr. Richard Gray joined Tyler Heart Institute as medical director in 2009. Dr. Gray specializes in valvular heart disease and artificial heart valves, coronary artery disease, and preventive cardiology. He is board certified in both internal medicine and cardiovascular disease. He received his medical training at the University of Texas, San Antonio, and completed his residency with the VA Greater Los Angeles Health Care System. Prior to joining the medical team at Cedars-Sinai Medical Center in Los Angeles, he completed an internship at the University of Vermont – Fletcher Allen Health Care and a fellowship at Cedars-Sinai Medical Center. As a cardiologist since 1975, Dr. Gray has focused his career on academic medicine, teaching, research, program development, and leadership as well as clinical medicine. Since 2002, Dr. Gray has been the medical director of Sutter Pacific Heart Centers at California Pacific Medical Center in San Francisco and Marin General Hospital in Marin County, California. From 1996 to 2002, Dr. Gray was chief of cardiology at Regions Hospital of St Paul Minnesota and director of Cardiovascular Services for Health Partners of Minneapolis-St. Paul, and from 1992 to 1996, professor and chair of the Department of Medicine at the University of North Dakota School of Medicine. From 1975 to 1993 he was staff associate cardiologist at Cedars-Sinai Medical Center, Los Angeles, California, serving from 1982 to 1992 as the director of Surgical Cardiology and from 1988 to 1990 he was the medical director of the Heart Transplant program at Cedars Sinai. Since 1977, Dr. Gray has been involved in numerous medical device development projects involving very early stage and small start-up as well as established corporate level activity. He has held appointments as professor of medicine at the University of California School of Medicine in Los Angeles, University of Minnesota, and at the University of North Dakota School of Medicine. He has been principal investigator on many cardiac research studies and has authored numerous peer review publications, abstracts, book chapters, and a textbook. Dr. Gray has been actively involved in the American Heart Association and the American College of Cardiology throughout his professional career. In 1991 he served as president of the former greater Los Angeles affiliate, and has served in various leadership capacities at the former Dakota affiliate, Northland affiliate, and recently, the San Francisco division board and is currently the Western States affiliate president-elect.

HeartSciences

Mark Hilz

CEO and Board Member

Mark has over 30 years’ experience as a President/CEO of multiple successful start-up companies and has a track record of succeeding with new technologies. He was CEO of INX a technology infrastructure consulting company that he founded as a startup subsidiary for a public company. It grew to $400 million in revenue with 15 offices, 2,000 customers, and 500 employees. The company was a NASDAQ listed company and was successfully sold to a private equity group in December 2011. Prior to that, Mark founded and ran as CEO, a technology logistics outsourcing firm that grew to over $160M in revenue with 1,100 employees in an 8-year span and was successful in taking the company public in an IPO as a NASDAQ listed company. Mark is also currently a member of the International Society for Computerized Electrocardiology (ISCE) Board of Trustees. ISCE a non-profit organization devoted to the advancement of electrocardiology through the application of computer methods.

HeartSciences

Andrew Simpson

Chairman

Andrew has extensive experience running and growing companies, as well as fund raising and M&A. He was the Group CEO of Peel Holdings, a large private company that controls over $15 billion of assets. He successfully achieved the strategic restructuring of the group by strengthening and creating new management teams; introduced key partners in several divisions involving $3 billion of investment; and successfully managed $5 billion of debt funding across multiple facilities. His tenure saw material asset growth and an increase in liquid assets by $1 billion. Prior to that, Andrew was Group Commercial Director and divisional CEO for a large U.K listed company which grew to $500 million in revenue and saw its stock quadruple in value during his involvement. He spent eight years working as an Investment Banker with Rothschild, generally focusing on growth businesses, and qualified as a Chartered Accountant with Price Waterhouse.